Families Left Behind

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
RAND
Study ID
NCT06854757
Status
Recruiting
Apply to this trial

Conditions

  • Grief
  • Grief Disorder, Prolonged
  • Overdose Accidental
  • Substance Use Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RIVER — BEHAVIORAL
    RIVER is a peer grief support process intervention developed by Peer Support Community Partners.
  • Enhanced care as usual — BEHAVIORAL
    The enhanced care as usual condition involves a psychoeducational booklet developed by What's Your Grief, as well as a list of local grief resources.

Study Details

The United States is facing unprecedented rates of drug overdose deaths, profoundly impacting millions of families who are left to navigate their grief. Those bereaved by overdose experience a unique form of grief characterized by feelings of guilt, shame, and blame, which can worsen their suffering and deter them from seeking help. Individuals coping with overdose loss often endure more severe health consequences compared to those grieving non-drug related deaths, including prolonged grief disorder, substance use disorders, PTSD, depression, and suicidal thoughts. Moreover, bereaved individuals, particularly those with a history of substance use, may engage in risky behaviors as a means of coping, further exacerbating the risk of overdose and mortality within this vulnerable population. Peer grief support interventions have emerged as a promising approach to assist those experiencing such losses. To combat these outcomes, we are collaborating with Peer Community Support Partners (PSCP) in a novel practice-research partnership to implement the RIVER peer grief support model. Though RIVER has shown success in community settings, it has yet to be rigorously evaluated. In a three-aim approach, this study aims to assess the effectiveness of the RIVER model while also enhancing and engaging grievers with support resources via medical examiner offices (MEOs), which routinely contact families during death investigations. This research represents a pivotal advancement in addressing the needs of the overlooked bereaved community, aligning with the NIH's Helping to End Addiction Long-term (HEAL) initiative to develop effective strategies against the opioid crisis. Together, community engagement and rigorous research efforts aim to enhance support for those affected by the tragedy of drug overdose.

Key Dates

Start date
Jun 13, 2025
Status verified
Aug 2025
Primary completion
Aug 29, 2026
Completion
Oct 31, 2030

Study Design

Enrollment
340 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Peer grief support + enhanced care as usual
    Participants in this arm will be matched with a peer grief support specialist who will provide support that aligns with the RIVER process model developed by Peer Community Support Partners. They will also receive a psychoeducational booklet and a list of local grief support resources (i.e., the enhanced care as usual condition).
  • Active Comparator: Enhanced care as usual
    Participants will receive a psychoeducational booklet and a list of local grief support resources.

Primary Outcome Measure

Participant Grief Symptoms [ Time Frame: Baseline, 3-month follow up, 6-month follow up, and 12-month follow up ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Jefferson County Coroner/Medical Examiner's OfficeBirminghamAlabama35203
Daniel Dye, MD
[email protected]
San Diego County Medical Examiner OfficeSan DiegoCalifornia92123
Jonathan Lucas, MD
[email protected]
Connecticut Office of the Chief Medical ExaminerFarmingtonConnecticut06032
James Gill, MD
[email protected]
Peer Support Community PartnersWatertownMassachusetts02472-

Find similar trials in Birmingham, AL

By research site
Jefferson County Coroner/Medical Examiner's Office· Birmingham, ALSan Diego County Medical Examiner Office· San Diego, CAConnecticut Office of the Chief Medical Examiner· Farmington, CTPeer Support Community Partners· Watertown, MA

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